The following data is part of a premarket notification filed by Roche Diabetes Care Ag with the FDA for Accu-chek Ultraflex Infusion Set.
| Device ID | K122686 |
| 510k Number | K122686 |
| Device Name: | ACCU-CHEK ULTRAFLEX INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | ROCHE DIABETES CARE AG KIRCHBERGSTRASSE 190 Burgdorf, CH Ch-3401 |
| Contact | Catherine Green |
| Correspondent | Catherine Green ROCHE DIABETES CARE AG KIRCHBERGSTRASSE 190 Burgdorf, CH Ch-3401 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-04 |
| Decision Date | 2012-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630888658 | K122686 | 000 |
| 04015630888610 | K122686 | 000 |
| 04015630888634 | K122686 | 000 |
| 04015630888627 | K122686 | 000 |